Clinical trials: Vertebral Fractures
Osteoporotic Vertebral Compression Fractures
SpineJack System Postmarket Registry
This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system.
- Trial name
- NCT04795765
- Testing
- SpineJack system, Balloon kyphoplasty, Vertebroplasty
- Where
- 12 sites in United States
- Volunteers
- 261 people
- Sponsor
- Stryker Instruments
Osteoporosis
Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis
Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)
- Trial name
- DIRECT (NCT00680953)
- Testing
- Denosumab, Alendronate sodium hydrate
- Where
- 4 sites in Japan
- Volunteers
- 1,262 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Vertebral Compression Fracture, Vertebral Compression
RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures
This study is a prospective, single-arm, multi-center, European clinical study designed to evaluate the clinical performance and safety of the AGN1 LOEP SV Kit for the treatment of painful VCFs.
- Conditions
- Vertebral Compression Fracture, Vertebral Compression, Vertebral Fracture
- Trial name
- NCT04821739
- Testing
- AGN1 LOEP SV Kit
- Where
- 3 sites in Germany, Spain
- Volunteers
- 100 people
- Sponsor
- AgNovos Healthcare, LLC
Osteoporotic Fracture of Vertebra
Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures
Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone interface, the ISS stabilization system has been developed.
- Trial name
- NCT04495439
- Testing
- Augmentation with the ISS Study System, Augmentation with PMMA
- Where
- Austria
- Volunteers
- 2 people
- Sponsor
- Nexilis AG
Osteoporosis, Postmenopausal
The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women
This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be…
- Trial name
- TOP (NCT01381588)
- Testing
- Fracture evaluation
- Where
- South Korea
- Volunteers
- 1,136 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Osteoporotic Vertebral Compression Fractures
Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures
The objective of this Post-Market Clinical Follow-Up Study is to evaluate the safety and performance of the Tripod-Fix in the treatment of vertebral compression fractures (VCF) resulting from osteoporosis.
- Trial name
- NCT06270173
- Testing
- Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix)
- Where
- 4 sites in Germany
- Volunteers
- 53 people
- Sponsor
- Wiltrom Co., Ltd.
Osteoporosis, Osteoporosis, Age-Related
Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
- Conditions
- Osteoporosis, Osteoporosis, Age-Related, Osteoporosis Localized to Spine, Age Related Osteoporosis
- Trial name
- NCT03512262
- Testing
- Abaloparatide
- Where
- 34 sites in United States, Italy and 1 more
- Volunteers
- 228 people
- Sponsor
- Radius Health, Inc.
Osteoporosis, Spinal Fractures
Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis
The purpose of this study is to evaluate the safety of intravenous infusion of fucosylated autologous bone marrow cells as a new therapy in patients with established osteoporosis by a prospective, single-center, open…
- Trial name
- CSM/OP/2011 (NCT02566655)
- Testing
- Fucosylated MSC for Osteoporosis
- Where
- Spain
- Volunteers
- 10 people
- Sponsor
- Red de Terapia Celular
Healthy, Osteopenia
Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break.
- Conditions
- Healthy, Osteopenia, Osteoporosis
- Trial name
- POROUS-preFX (NCT06567054)
- Testing
- Measurements with the POROUS R3C ultrasound device at the midshaft tibia, DXA measurement of the hip and lumbar spine, DXA-based Vertebral Fracture Assessment (VFA)
- Where
- 6 sites in Austria, Germany and 1 more
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- POROUS GmbH
Spinal Fractures
PASS MIS® Post-market Clinical Follow-up
Prospective, multicenter non comparative and observational study (post-market clinical follow-up).
- Trial name
- NCT02931266
- Testing
- PASS MIS®
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Medicrea International
Male Osteoporosis
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.
- Trial name
- NCT00439647
- Testing
- Zoledronic acid 5 mg iv
- Where
- 128 sites in Argentina, Australia and 21 more
- Volunteers
- 1,199 people
- Sponsor
- Novartis Pharmaceuticals
Healthy, Osteopenia
Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break.
- Conditions
- Healthy, Osteopenia, Osteoporosis
- Trial name
- POROUS-BMD (NCT07187518)
- Testing
- Measurements with the POROUS R4C ultrasound device at the midshaft tibia, DXA measurement of the hip and lumbar spine
- Where
- 2 sites in Germany
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- POROUS GmbH
Postmenopausal Osteoporosis
VERtebral Fracture Treatment Comparisons in Osteoporotic Women
The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.
- Trial name
- VERO (NCT01709110)
- Testing
- Teriparatide, Risedronate, Calcium
- Where
- 103 sites in United States, Argentina and 13 more
- Volunteers
- 1,366 people
- Sponsor
- Eli Lilly and Company
Osteoporosis
Impact of Vertebral Fracture Knowledge on Persistence in Subjects Taking Glucocorticoid Therapy
To evaluate the effect of subject knowledge of their disease status on persistence in subjects receiving Actonel 5 mg daily over a 12-month period for the prevention and treatment of GIO.
- Trial name
- ACTIVATE (NCT00616694)
- Testing
- Actonel
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- Sanofi
Spinal Fractures
A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis
Doctors are studying an investigational treatment to be used during the vertebroplasty procedure when treating vertebral compression fractures (spine fractures) that may help to reduce pain and restore mobility.
- Trial name
- NCT00290862
- Testing
- Percutaneous Vertebral Augmentation of compression fractures
- Where
- 18 sites in United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- Orthovita d/b/a Stryker
Vertebral Compression Fracture
The Purpose of This Study is to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System
The purpose of this pilot study is to evaluate the safety and performance of the V-STRUT© Transpedicular Vertebral System for the treatment of vertebral compression fractures of the thoracic or lumbar spine.
- Trial name
- NCT03580434
- Testing
- V-STRUT
- Where
- 3 sites in France
- Volunteers
- 9 people
- Sponsor
- Hyprevention
Disc Degenerative Disease, Spondylolisthesis
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity
- Trial name
- NCT02252185
- Testing
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Where
- 8 sites in China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
Pathologic Fracture of the Vertebra Due to Osteoporosis
Clinical Evaluation of the Crosstrees Pod™ in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4 - L5) in Adult Patients
The clinical trial is being conducted to evaluate the performance of the Crosstrees System in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty.
- Trial name
- NCT00933036
- Testing
- Crosstrees Pod system for PVA
- Where
- 9 sites in United States
- Volunteers
- 135 people
- Sponsor
- Crosstrees Medical Inc.
Kyphoplasty, Vertebroplasty
A Prospective, Single-center, Observational Clinical Outcomes Study for Vertebral Compression Fractures Treated With the OsteoPearl Biological Allograft Implants
The primary objective of this observational study is to evaluate fracture stability through longitudinal assessment of subject-reported pain following treatment with the OsteoPearl Biological Allograft in men and women aged ≥50…
- Conditions
- Kyphoplasty, Vertebroplasty, Vertebral Compression Fracture, Allograft
- Trial name
- PEARL ONE (NCT07561489)
- Testing
- Allograft
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Lenoss Medical
Osteoporosis
Trial to Evaluate Tibolone in the Treatment of Osteoporosis (P06468)
Tibolone 1.25 mg is an effective treatment for the prevention of osteoporosis and is expected to be effective in preventing fractures in osteoporotic women.
- Trial name
- LIFT (NCT00519857)
- Testing
- Tibolone
- Volunteers
- 4,534 people
- Sponsor
- Organon and Co